Tenizide 20mg+12.5mg

Tablet
Olmesartan Medoxomil + Hydrochlorothiazide
Unimed Unihealth MFG. Ltd

Other Strength:

Alternative:
- Olmesan Plus 20mg+12.5mg
- Orbas Plus 20mg+12.5mg
- Xyotil Plus 20mg+12.5mg
- Ransys Plus 20mg+12.5mg
- Olmecar Plus 20mg+12.5mg



Tenizide
Presentation
Tenizide 20/12.5 tablet: Light orange, diamond shaped, scored on one side, U engraved on other side, film coated tablet; each tablet contains Olmesartan Medoxomil USP 20mg and Hydrochlorothiazide BP 12.5mg.

Indications
Treatment of essential hypertension. Tenizide fixed dose combination is indicated in adult patients whose blood pressure is not adequately controlled on Olmesartan Medoxomil alone.

Dosage and administration
Adults: Tenizide is not for use as initial therapy, but in patients whose blood pressure is not adequately controlled by 20mg Olmesartan Medoxomil alone. Tenizide is administered once daily, with or without food. When clinically appropriate, direct change from monotherapy with 20mg Olmesartan Medoxomil to the fixed combination may be considered, taking into account that the antihypertensive effect of Olmesartan Medoxomil is maximal by about 8 weeks after initiating therapy.

Elderly (age 65 years or older): In elderly patients the same dosage of the combination is recommended as for adults.

Renal impairment: When Olmesartan Medoxomil-Hydrochlorothiazide is used in patients with mild to moderate renal impairment (creatinine clearance of 30-60 ml/min) periodic monitoring of renal function is advised. Olmesartan Medoxomil-Hydrochlorothiazide is contra-indicated in patients with severe renal impairment (creatinine clearance < 30 mL/min).

Hepatic impairment: Olmesartan Medoxomil-Hydrochlorothiazide should be used with caution in patients with mild to moderate hepatic impairment. In patients with moderate hepatic impairment, an initial dose of 10mg Olmesartan Medoxomil once daily is recommended and the maximum dose should not exceed 20mg once daily. Close monitoring of blood pressure and renal function is advised in hepatically-impaired patients who are receiving diuretics and/or other antihypertensive agents. There is no experience of Olmesartan Medoxomil in patients with severe hepatic impairment. Olmesartan Medoxomil-Hydrochlorothiazide should not be used in patients with severe hepatic impairment, cholestasis and biliary obstruction.

Paediatric population: The safety and efficacy of Olmesartan Medoxomil-Hydrochlorothiazide in children and adolescents below 18 years has not been established. No data are available.

Contra-indications, warnings etc.
Contra-indications: Hypersensitivity to the active substances, to any of the excipients or to other sulfonamide-derived substances (since hydrochlorothiazide is a sulfonamide-derived medicinal product), severe renal impairment (creatinine clearance < 30 mL/min), refractory hypokalaemia, hypercalcaemia, hyponatraemia and symptomatic hyperuricaemia, severe hepatic impairment, cholestasis and biliary obstructive disorders.

Warnings:
Symptomatic hypotension, especially after the first dose, may occur in patients who are volume and/or sodium depleted by vigorous diuretic therapy, dietary salt restriction, diarrhoea or vomiting. Such conditions should be corrected before the administration of Olmesartan Medoxomil-Hydrochlorothiazide.

Use in Pregnancy and Lactation:
Given the effects of the individual components in this combination product on pregnancy, the use of Olmesartan Medoxomil-Hydrochlorothiazide is not recommended during the first trimester of pregnancy. The use of Olmesartan Medoxomil-Hydrochlorothiazide is contra-indicated during the 2nd and 3rd trimester of pregnancy. Because no information is available regarding the use of Olmesartan Medoxomil-Hydrochlorothiazide during breast feeding, it is not recommended and alternative treatments with better established safety profiles during breast-feeding are preferable, especially while nursing a newborn or preterm infant. Hydrochlorothiazide is excreted in human milk in small amounts. Thiazides in high doses causing intense diuresis can inhibit the milk production. The use of Olmesartan Medoxomil-Hydrochlorothiazide during breast feeding is not recommended. If Olmesartan Medoxomil-Hydrochlorothiazide is used during breast feeding, doses should be kept as low as possible.

Drug Interactions:
Reversible increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with angiotensin converting enzyme inhibitors and, rarely, with angiotensin-II antagonists. In addition, renal clearance of lithium is reduced by thiazides and consequently the risk of lithium toxicity may be increased. Therefore use of Olmesartan Medoxomil-Hydrochlorothiazide and lithium in combination is not recommended. If use of the combination proves necessary, careful monitoring of serum lithium levels is recommended. NSAIDs (i.e. acetylsalicylic acid (> 3 g/day), COX-2 inhibitors and non-selective NSAIDs) may reduce the antihypertensive effect of thiazide diuretics and angiotensin-II antagonists. In some patients with compromised renal function (e.g. dehydrated patients or elderly patients with compromised renal function) the co-administration of angiotensin-II antagonists and agents that inhibit cyclo-oxygenase may result in further deterioration of renal function, including possible acute renal failure, which is usually reversible. Therefore, the combination should be administered with caution, especially in the elderly. Patients should be adequately hydrated and consideration should be given to monitoring of renal function after initiation of concomitant therapy and periodically thereafter.

Side-effects:
The most commonly reported adverse reactions during treatment with Olmesartan Medoxomil-Hydrochlorothiazide are headache, dizziness and fatigue. Other common side effects are chest pain, fatigue, influenza-like symptoms, peripheral oedema. Hydrochlorothiazide may cause volume depletion which may lead to electrolyte imbalance.

Overdose:
The most likely manifestations of Olmesartan Medoxomil overdose are expected to be hypotension and tachycardia; bradycardia might also occur. Overdose with hydrochlorothiazide is associated with electrolyte depletion (hypokalaemia, hypochloraemia) and dehydration resulting from excessive diuresis. The most common signs and symptoms of overdose are nausea and somnolence. Hypokalaemia may result in muscle spasm and/or accentuate cardiac arrhythmias associated with the concomitant use of digitalis glycosides or certain anti-arrhythmic medicinal products. No specific information is available on the effects or treatment of Olmesartan Medoxomil-Hydrochlorothiazide overdose. The patient should be closely monitored and the treatment should be symptomatic and supportive. Management depends upon the time since ingestion and the severity of the symptoms. Suggested measures include induction of emesis and/or gastric lavage. Activated charcoal may be useful in the treatment of overdose. Serum electrolytes and creatinine should be monitored frequently. If hypotension occurs, the patient should be placed in a supine position, with salt and volume replacements given quickly.

Pharmaceutical precautions
Store in a cool and dry place, protected from light.

Packaging quantity
Tenizide 20/12.5 tablet: Carton containing 28 tablets in alu-alu bli

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